BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM SOLEX 7 CATHETER

    MDR report key: 13934849 · Received March 29, 2022

    Report

    Report Number
    3010617000-2022-00289
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Date of Event
    March 2, 2022
    Report Date
    April 29, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075305
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZOLL HAS RECEIVED THE SOLEX 7 CATHETER (LOT #164851) FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    LOT # WAS CORRECTED IN B5 (DESCRIBE EVENT OR PROBLEM) AND D4 (SUSPECT MEDICAL DEVICE - LOT #) THE CUSTOMER REPORTED COMPLAINT OF "A SOLEX 7 CATHETER (LOT #162827) LEAK" WAS CONFIRMED DURING THE FUNCTIONAL TESTING. A PINHOLE LEAK WAS OBSERVED AT THE SERPENTINE BALLOON'S PROXIMAL END (2ND LOOP) DURING THE FUNCTIONAL PRESSURE LEAK TEST. THE PROBABLE ROOT CAUSE OF THE PINHOLE LEAK WAS A LATENT MATERIAL DEFECT. UPON VISUAL INSPECTION, NO PHYSICAL DAMAGE WAS NOTED ON THE CATHETER AND OBSERVED THAT BLOOD HAD ACCUMULATED/DRIED UP ON THE CATHETER'S SERPENTINE BALLOON AND LUER TUBINGS. ALL INFUSION PORTS AND LUMENS WERE FLUSHED WITHOUT RESISTANCE DURING THE FUNCTIONAL TESTING. THE CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE DURING THE FUNCTIONAL PRESSURE LEAK TEST. UPON PRESSURIZING THE CATHETER, A PINHOLE LEAK WAS OBSERVED AT THE PROXIMAL END (2ND LOOP) OF THE SERPENTINE BALLOON, THUS, CONFIRMING THE REPORTED COMPLAINT. IT IS UNLIKELY THAT THE DEFECTIVE CATHETER WAS SHIPPED. ALL CATHETERS ARE 100% INSPECTED FOR LEAKS DURING MANUFACTURING BY SUBJECTING THEM TO PRESSURE TESTING. ONLY UNITS THAT PASSED ARE MOVED TO THE FOLLOWING PROCESS. HISTORICAL COMPLAINTS WERE REVIEWED FOR INFORMATION RELATED TO THE REPORTED COMPLAINT, AND THERE WAS NO PREVIOUS HISTORY OF COMPLAINTS REPORTED FOR THE SOLEX 7 CATHETER WITH LOT #162827.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR FEVER CONTROL USING A SOLEX 7 CATHETER (LOT #164851) PLACED IN THE RIGHT INTERNAL JUGULAR. AT THE START OF THE TREATMENT, THE PATIENT'S TEMPERATURE WAS 106°F, AND THE TARGET TEMPERATURE WAS 99°F. AFTER APPROXIMATELY FOUR AND A HALF HOURS, THE THERMOGARD XP IVTM SYSTEM (SN (B)(4)) GENERATED AN "AIR TRAP WARNING" ALARM. THE CUSTOMER NOTED AN EMPTY 500 ML SALINE BAG, BLOOD-TINGED IN START-UP KIT (SUK) TUBING, AND NO LEAKED SALINE NOTED AROUND THE PATIENT OR ON THE FLOOR AROUND THE THERMOGARD SYSTEM. THE TEMPERATURE AT THE TIME OF THE ISSUE WAS 99.6°F. AN ARTERIAL CATHETER WAS PLACED AS THE PATIENT WAS ON MULTIPLE PRESSORS. THE CUSTOMER SUSPECTS A CATHETER LEAK AND 500 ML OF SALINE INFUSION INTO THE PATIENT'S BODY. ZOLL TECH SUPPORT ADVISED THE CUSTOMER TO STOP THE IVTM THERAPY AND REMOVE THE CATHETER. THE CUSTOMER REMOVED THE CATHETER, AND A REGULAR TRIPLE LUMEN CATHETER WAS INSERTED. THE PATIENT'S TEMPERATURE WAS REGULATED USING THE COOLING BLANKETS. THE CUSTOMER REPORTED NO DEVICE MALFUNCTION ON THE THERMOGARD SYSTEM AND WAS PLACED BACK FOR CLINICAL USE. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    THE PATIENT WAS TREATED FOR FEVER CONTROL USING A SOLEX 7 CATHETER (LOT #162827) PLACED IN THE RIGHT INTERNAL JUGULAR. AT THE START OF THE TREATMENT, THE PATIENT'S TEMPERATURE WAS 106°F, AND THE TARGET TEMPERATURE WAS 99°F. AFTER APPROXIMATELY FOUR AND A HALF HOURS, THE THERMOGARD XP IVTM SYSTEM (SN (B)(6)) GENERATED AN "AIR TRAP WARNING" ALARM. THE CUSTOMER NOTED AN EMPTY 500 ML SALINE BAG, BLOOD-TINGED IN START-UP KIT (SUK) TUBING, AND NO LEAKED SALINE NOTED AROUND THE PATIENT OR ON THE FLOOR AROUND THE THERMOGARD SYSTEM. THE TEMPERATURE AT THE TIME OF THE ISSUE WAS 99.6°F. AN ARTERIAL CATHETER WAS PLACED AS THE PATIENT WAS ON MULTIPLE PRESSORS. THE CUSTOMER SUSPECTS A CATHETER LEAK AND 500 ML OF SALINE INFUSION INTO THE PATIENT'S BODY. ZOLL TECH SUPPORT ADVISED THE CUSTOMER TO STOP THE IVTM THERAPY AND REMOVE THE CATHETER. THE CUSTOMER REMOVED THE CATHETER, AND A REGULAR TRIPLE LUMEN CATHETER WAS INSERTED. THE PATIENT'S TEMPERATURE WAS REGULATED USING THE COOLING BLANKETS. THE CUSTOMER REPORTED NO DEVICE MALFUNCTION ON THE THERMOGARD SYSTEM AND WAS PLACED BACK FOR CLINICAL USE. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50818 ZOLL IVTM SOLEX 7 CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION SL-2593 162827 00849111075305

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown